It seems that the answer is now ‘yes’. Closing point report:
Stealth Biotherapeutics said that the FDA would not complete the Tuesday’s deadline to approve or reject the company’s drug, auppritide. It was demanding regulatory withdrawal of almipritide for a rare disease called Barth syndrome, affecting only 150 people in the US and causing heart abnormalities and muscle weakness. About 85% of patients do not make it before the age of 5.
In a statement on Tuesday, Stealth said that “the US Food and Drug Administration (FDA) communicated that it would not complete the date of today’s prescription drug user fees action (PDUFA) for its new drug application.”
Is there a delay due to specific issues related to medicine? The answer does not seem.
Typically, FDA does not miss the dates of PDufa until it requests more data or increases safety or manufacturing concerns. Those types of delays are usually informed to companies with new decision dates.
Robert f. Under Kennedy Junior, FDA and other US health agencies have a clear delay between heavy upheaval periods. The new HHS secretary and Dogi of Elon Musk has fired thousands of employees from FDA, CBER director Peter Marx, and are looking at the integrated offices in the agency.
There is a possibility of more delay:
An existing FDA employee who requested oblivion previously confirmed from the concluding points that the drug and device reviewers’ hundreds “have reused themselves to look for new jobs. Former FDA Commissioner Scott Gottlib made a similar comment in a CNBC interview last week.
Stay to see if it is united delay or part of a normal trend.
